Advanced Solid Tumors
Conditions
Brief summary
A Phase I open label study of AS1411 in advanced solid tumours. Objectives include determining the MTD and DLT of AS1411, to determine the PK profile of AS1411 and to obtain preliminary evidence of clinical and biological responses to AS1411 therapy.
Interventions
DRUGAS1411
I.v. 4-7 days, 1-40 mg/kg/day
Sponsors
Antisoma Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with advanced solid tumours that were refractory to conventional/standard treatment * Age \>/ 18 years * ECOG performance status \</ 2 (Karnofsky \>/60% * Life expectancy \>/ 8 weeks * Adequate organ and marrow function
Exclusion criteria
* Radiotherapy or chemotherapy in the 4 weeks before study entry (6 weeks for nitrosourea or mitomycin C * Lack of recovery from adverse events (AEs) caused by agents administered before study entry; current use of other investigational agent(s) * Uncontrolled brain metastases including a need for corticosteroid therapy * Pregnancy * Uncontrolled intercurrent illness * Psychiatric illness/social situations that could limit compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of AS1411 | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the pharmacokinetic (PK) distribution and profile of AS1411 | — |
| To obtain preliminary evidence of clinical and biological responses to AS1411 | — |
Countries
United States
Outcome results
None listed